BioSpace News Archive

K-One MediTech To Begin Production of CE approved 15-Minute Antigen Test Solution

Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Clinical Enterprise, Inc. d/b/a empowerDX, today announced its at-home COVID-19 testing kit received FDA-emergency use authorization for children three years and older.

AliveCor, a leading innovator in FDA-cleared personal electrocardiogram technology and services, announced that the US International Trade Commission issued a Notice of Institution of an Investigation into Apple’s alleged infringement of three AliveCor patents.

RYBREVANT™ is the first fully-human, bispecific antibody approved in lung cancer Simultaneous FDA approval of a companion diagnostic aids in the identification of exon 20 insertion mutations

Guardant360 ® CDx Receives FDA Approval as Companion Diagnostic for Janssen’s RYBREVANT™ (amivantamab-vmjw) for Use in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Guardant Health blood test identifies patients with EGFR exon 20 insertion mutations who may benefit from targeted treatment with RYBREVANT™ after progressing on or after platinum-based chemotherapy

Ever increasing pool of patients with atopic dermatitis, growing investment in research & development for novel drugs and rising awareness will improve sales prospects

Meiji Seika Pharma Co., Ltd. announced that the bioequivalence of DMB-3115, a proposed ustekinumab biosimilar, has been demonstrated in phase I clinical trial compared to the reference products marketed in Europe and the United States.

Evofem Biosciences, Inc. announced the closing of its previously announced underwritten public offering of 50 million shares of its common stock and accompanying two-year warrants to purchase an aggregate of up to 50 million shares of common stock.

Disc Medicine, a company dedicated to the discovery and development of novel therapeutic candidates for serious and debilitating hematologic diseases, announced that John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc Medicine, will provide a corporate presentation on Thursday, June 3, 2021 at 2:00 p.m. ET at the Jefferies Virtual Healthcare Conference.